Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Arog Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Treatments: Drug: Fludarabine; Drug: G-CSF; Drug: Placebo Oral Tablet; Drug: Cytarabine; Drug: Crenolanib; Drug: Idarubicin; Drug: Mitoxantrone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03250338

ARO-013

2017-001600-29 (EudraCT Number)

Details and patient eligibility

About

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Enrollment: 322 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
2. Presence of FLT3-ITD and/or D835 mutation(s)
3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
4. Age ≥ 18 years and ≤ 75 years
5. Adequate hepatic function
6. Adequate renal functions
7. ECOG performance status ≤ 3

Exclusion criteria

1. Known clinically active central nervous system(CNS) leukemia
2. Severe liver disease
3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

322 participants in 2 patient groups, including a placebo group

Crenolanib

Experimental group

Description:

Crenolanib following salvage chemotherapy

Treatment:

Drug: Idarubicin

Drug: Fludarabine

Drug: Crenolanib

Drug: Cytarabine

Drug: Mitoxantrone

Drug: G-CSF

Placebo

Placebo Comparator group

Description:

Placebo following salvage chemotherapy

Treatment:

Drug: Placebo Oral Tablet

Drug: Idarubicin

Drug: Fludarabine

Drug: Cytarabine

Drug: Mitoxantrone

Drug: G-CSF